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FDA 510(k)

NEORAY DR 2520 DIGITAL IMAGING SYSTEM

K-Number: K083048 · 2008-11-21

ApplicantPortavision Medical, LLC
Decision Date2008-11-21
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEORAY DR 2520 DIGITAL IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Portavision Medical, LLC. It received FDA 510(k) clearance on 2008-11-21 under 510(k) number K083048. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEORAY DR 2520 DIGITAL IMAGING SYSTEM?

NEORAY DR 2520 DIGITAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-11-21. The listed applicant is Portavision Medical, LLC. The 510(k) number is K083048.

When did NEORAY DR 2520 DIGITAL IMAGING SYSTEM receive FDA 510(k) clearance?

NEORAY DR 2520 DIGITAL IMAGING SYSTEM received FDA 510(k) clearance on 2008-11-21, under 510(k) number K083048.

Who is the listed applicant for NEORAY DR 2520 DIGITAL IMAGING SYSTEM?

The FDA 510(k) record lists Portavision Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEORAY DR 2520 DIGITAL IMAGING SYSTEM?

The FDA product code for NEORAY DR 2520 DIGITAL IMAGING SYSTEM is IZL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Portavision Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212557Virtual C DRF-NEO Digital Imaging SystemK211191Virtual C DRF Digital Imaging SystemK191503MobileRay Pulse SE Digital Imaging System

Related Devices (Code: IZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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